erx.spa.147 leuprolide acetate (eligard, fensolvi, lupaneta … · 2020. 12. 23. · leuprolide...

Clinical Policy: Leuprolide Acetate (Eligard, Fensolvi, Lupaneta Pack, Lupron Depot, Lupron Depot-PED) Reference Number: ERX.SPA.147 Effective date: 10.01.16 Last Review Date: 11.20 Line of Business: Commercial, Medicaid Revision Log

See Important Reminder at the end of this policy for important regulatory and legal information.

Description Leuprolide acetate (Eligard®, Fensolvi®, Lupaneta Pack® [with norethindrone acetate tablets], Lupron Depot®, Lupron Depot-Ped®) is a gonadotropin-releasing hormone (GnRH) agonist.

FDA Approved Indication(s): Leuprolide acetate is indicated for: • Palliative treatment of advanced prostate cancer:

o Leuprolide acetate injection o Eligard o Lupron Depot (7.5, 22.5, 30, 45)

• Management of endometriosis, including pain relief and reduction of endometriotic lesions: o Lupron Depot (3.75, 11.25) o Lupaneta Pack (3.75, 11.25) Limitation(s) of use: Initial treatment course is limited to 6 months and use is not recommended longer than a total of 12 months due to concerns about adverse impact on bone mineral density.

• Preoperative hematologic improvement of patients with anemia caused by uterine leiomyomata [fibroids] administered concomitantly with iron therapy: o Lupron Depot (3.75, 11.25) Limitation of use: the recommended treatment is limited to one injection (3 months)

• Treatment of children with central precocious puberty (CPP): o Fensolvi o Leuprolide acetate o Lupron Depot-Ped (7.5, 11.25, 15, 30)

Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.

Health plan approved formularies should be reviewed for all coverage determinations. Requirements to use preferred alternative agents apply only when such requirements align with the health plan approved formulary.

It is the policy of health plans affiliated with Envolve Pharmacy Solutions™ that leuprolide acetate injection, Eligard, Fensolvi, Lupaneta Pack, Lupron Depot, and Lupron Depot-Ped are medically necessary when the following criteria are met:

I. Initial Approval CriteriaA. Prostate Cancer (must meet all):

1. Diagnosis of prostate cancer; 2. Request is for one of the following (a, b, or c):

a. Leuprolide acetate injection; b. Eligard; c. Lupron Depot (7.5 mg, 22.5 mg, 30 mg, 45 mg);

3. Prescribed by or in consultation with an oncologist or urologist; 4. Age ≥ 18 years;

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CLINICAL POLICY Leuprolide Acetate

5. Request meets one of the following (a, b, or c):* a. Leuprolide acetate injection (SC): Dose does not exceed 1 mg per day; b. Eligard (SC)/Lupron Depot (IM): Dose does not exceed 7.5 mg per month, 22.5 mg per 3

months, 30 mg per 4 months, 45 mg per 6 months; c. Dose is supported by practice guidelines or peer reviewed literature for the relevant off-

label use (prescriber must submit supporting evidence). *Prescribed regimen must be FDA-approved or recommended by NCCN

Approval duration: 12 months

B. Endometriosis (must meet all): 1. Diagnosis of endometriosis; 2. Request is for one of the following (a or b):

a. Lupron Depot; b. Lupaneta Pack (3.75 mg, 11.25 mg);

3. Prescribed by or in consultation with a gynecologist; 4. Age ≥ 18 years;5. Endometriosis as a cause of pain is one of the following (a or b):

a. Surgically confirmed; b. Clinically suspected and member has failed a 3-month trial of one of the

following agents within the last year or has a documented intolerance or contraindication to the agent (i, ii, or iii): i. A non-steroidal anti-inflammatory drug; ii. An oral or depot injection contraceptive; iii. A progestin;

6. If request is for Lupaneta Pack, medical justification supports inability to use Lupron Depot (e.g., contraindications to the excipients);

7. Dose does not exceed 3.75 mg per month or 11.25 mg per 3 months. Approval duration: 6 months Total duration of therapy should not exceed 12 months.

C. Uterine Fibroids (must meet all): 1. Diagnosis of anemia secondary to uterine leiomyomata (fibroids) confirmed by ultrasound; 2. Request is for Lupron Depot (3.75 mg, 11.25 mg); 3. Prescribed by or in consultation with a gynecologist; 4. Age ≥ 18 years;5. Prescribed preoperatively to reduce fibroid size and improve hematologic control; 6. Dose does not exceed 3.75 mg per month or 11.25 mg per 3 months. Approval duration: 3 months Total duration of therapy should not exceed 6 months.

D. Central Precocious Puberty (must meet all): 1. Diagnosis of CPP confirmed by all of the following (a, b, and c):

a. Elevated basal concentration of luteinizing hormone (LH) (i.e., > 0.2 - 0.3 mIU/L) or leuprolide-stimulated LH (i.e., > 3.3 - 5 IU/L);* *Pubertal threshold dependent on assay used.

b. Bone age advanced > 1 year beyond chronological age; c. Age at onset of secondary sex characteristics (i or ii):

i. Female: < 8 years; ii. Male: < 9 years;

2. Request is for one of the following (a, b or c): a. Fensolvi; b. Leuprolide acetate; c. Lupron Depot Ped: 7.5 mg, 11.25 mg, 15 mg, 30 mg;

3. Prescribed by or in consultation with a pediatric endocrinologist; 4. Member meets one of the following age requirements (a or b):

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a. Female: 2 - 11 years; b. Male: 2 - 12 years;

5. Dose does not exceed the following (a, b, c or d): a. Diagnostic use: Leuprolide acetate (SC): 20 mcg/kg or as needed; b. Therapeutic use: Fensolvi: 45 mg per 6 months; c. Therapeutic use: Leuprolide acetate (SC): Initial: 50 mcg/kg per day; titrate dose upward

by 10 mcg/kg per day if down-regulation is not achieved (higher mg/kg doses may be required in younger children);

d. Therapeutic use: Lupron Depot-Ped (IM): 15 mg per month (1 month formulation) or 30 mg per 3 months (3 month formulation) (weight-based dosing).


E. Breast and Ovarian Cancer (off-label) (must meet all): 1. Diagnosis of breast or ovarian cancer (including fallopian tube and primary peritoneal

cancer); 2. Request is for one of the following (a or b):

a. Breast cancer: Lupron Depot 3.75; b. Ovarian cancer: Lupron Depot 3.75 mg or 11.25 mg;

3. Prescribed by or in consultation with an oncologist; 4. Age ≥ 18 years;5. Request meets one of the following (a, b, or c):*

a. Breast or ovarian cancer: Dose does not exceed 3.75 mg per month; b. Ovarian cancer: Dose does not exceed 11.25 mg per 3 months; c. Dose is supported by practice guidelines or peer-reviewed literature for the

relevant off- label use (prescriber must submit supporting evidence). *Prescribed regimen must be FDA-approved or recommended by NCCN


F. Gender Dysphoria (off-label) (must meet all): 1. Diagnosis of gender dysphoria: 2. Request is not for Lupaneta Pack; 3. Prescribed by or in consultation with an endocrinologist and an expert in gender dysphoria

and transgender medicine (e.g., mental health professional such as psychologist, psychiatrist);

4. Age and pubertal development - meets (a or b): a. Member has reached or passed through Tanner Stage 2* and is < 18 years of age;

*Age ranges approximating Tanner Stage 2 pubertal development extend from 8 to 13 years of age in girls and 9 to 14 years of age in boys.

b. Member is ≥ 18 years of age and has failed to achieve physiologic hormone levels withgender-affirming hormonal therapy (e.g., estrogen, testosterone) unless contraindicated or clinically significant adverse effects are experienced;

5. Member demonstrates understanding of expected GnRH analogue treatment outcomes and has given consent for such treatment;

6. If member has a psychiatric comorbidity, member is followed by mental health provider; 7. Psychosocial support will be provided during treatment; 8. Dose is within FDA maximum limit for any FDA-approved indication or is supported by

practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).


G. Salivary Gland Tumors (off-label) (must meet all): 1. Diagnosis of salivary gland tumors; 2. Disease is androgen receptor positive and recurrent, unresectable, or metastatic; 3. Prescribed by or in consultation with an oncologist;

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4. Request is for one of the following (a or b): a. Eligard; b. Lupron Depot (7.5 mg, 22.5 mg);

5. Dose is within FDA maximum limit for any FDA-approved indication or is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). *Prescribed regimen must be FDA-approved or recommended by NCCN


H. Other diagnoses/indications 1. Refer to ERX.PA.01 if diagnosis is NOT specifically listed under section III

(Diagnoses/Indications for which coverage is NOT authorized).

II. Continued TherapyA. Prostate Cancer (must meet all):

1. Currently receiving medication via a health plan affiliated with Envolve Pharmacy Solutions, or documentation supports that member is currently receiving leuprolide acetate or Eligard/Lupron Depot for prostate cancer and has received this medication for at least 30 days;

2. Request is for one of the following (a, b, or c): a. Leuprolide acetate injection; b. Eligard; c. Lupron Depot (7.5 mg, 22.5 mg, 30 mg, 45 mg);

3. Member is responding positively to therapy; 4. If request is for a dose increase, request meets any of the following (a, b, or c):*

a. Leuprolide acetate injection (SC): New dose does not exceed: 1 mg per day; b. Eligard (SC)/Lupron Depot (IM): New dose does not exceed 7.5 mg per month, 22.5 mg

per 3 months, 30 mg per 4 months, or 45 mg per 6 months; c. New dose is supported by practice guidelines or peer-reviewed literature for the relevant

off-label use (prescriber must submit supporting evidence). *Prescribed regimen must be FDA-approved or recommended by NCCN


B. Endometriosis (must meet all): 1. Currently receiving medication via a health plan affiliated with Envolve Pharmacy Solutions or

member has previously met initial approval criteria; 2. Request is for Lupron Depot/Lupaneta Pack (3.75 mg, 11.25 mg); 3. Member is responding positively to therapy as evidenced by, including but not limited to,

improvement in any of the following parameters: improvement in dysmenorrhea, dyspareunia, pelvic pain/induration/tenderness, size of endometrial lesions;

4. If request is for a dose increase, new dose does not exceed 3.75 mg per month or 11.25 mg per 3 months.

Approval duration: 6 months Total duration of therapy should not exceed 12 months.

C. Uterine Fibroids (must meet all): 1. Currently receiving medication via a health plan affiliated with Envolve Pharmacy Solutions or

member has previously met initial approval criteria; 2. Request is for Lupron Depot (3.75 mg, 11.25 mg); 3. Member is responding positively to therapy; 4. If request is for a dose increase, new dose does not exceed 3.75 mg per month or 11.25 mg

per 3 months. Approval duration: 3 months Total duration of therapy should not exceed 6 months.

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D. Central Precocious Puberty (must meet all): 1. Currently receiving medication via a health plan affiliated with Envolve Pharmacy Solutions or

member has previously met initial approval criteria; 2. Request is for one of the following (a, b, or c):

a. Fensolvi; b. Leuprolide acetate; c. Lupron Depot Ped: 7.5 mg, 11.25 mg, 15 mg, 30 mg;

3. Member is responding positively to therapy as evidenced by, including but not limited to, improvement in any of the following parameters: decreased growth velocity, cessation of menses, softening of breast tissue or testes, arrested pubertal progression;

4. Member meets one of the following age requirements (a or b): a. Female: ≤ 11 years;b. Male: ≤ 12 years;

5. If request is for a dose increase, new dose does not exceed one of the following (a, b, or c): a. Leuprolide acetate (SC): Initial: 50 mcg/kg per day; titrate dose upward by 10 mcg/kg per

day if down-regulation is not achieved (higher mg/kg doses may be required in younger children);

b. Lupron Depot-Ped (IM): 15 mg per month (1 month formulation) or 30 mg per 3 months (3 month formulation) (dosing is weight-based).

c. Fensolvi: 45 mg per 6 months. Approval duration: 12 months

E. Breast and Ovarian Cancer (off-label) (must meet all): 1. Currently receiving medication via a health plan affiliated with Envolve Pharmacy Solutions,

or documentation supports that member is currently receiving Lupron Depot for breast or ovarian cancer and has received this medication for at least 30 days;

2. Request is for one of the following (a or b): a. Breast cancer: Lupron Depot 3.75 mg; b. Ovarian cancer: Lupron Depot 3.75 mg or 11.25 mg;

3. Member is responding positively to therapy; 4. If request is for a dose increase, request meets one of the following (a, b, or c):*

a. Breast or ovarian cancer: New dose does not exceed 3.75 mg per month; b. Ovarian cancer: New dose does not exceed 11.25 mg per 3 months; c. New dose is supported by practice guidelines or peer-reviewed literature for the relevant

off-label use (prescriber must submit supporting evidence). *Prescribed regimen must be FDA-approved or recommended by NCCN


F. Gender Dysphoria (off-label) (must meet all): 1. Currently receiving medication via a health plan affiliated with Envolve Pharmacy Solutions or

member has previously met initial approval criteria; 2. Member is responding positively to therapy; 3. If request is for a dose increase, new dose is within FDA maximum limit for any FDA-

approved indication or is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).


G. Salivary Gland Tumors (off-label) (must meet all): 1. Currently receiving medication via a health plan affiliated with Envolve Pharmacy Solutions or

member has previously met initial approval criteria; 2. Request is for one of the following (a or b):

a. Eligard; b. Lupron Depot (7.5 mg, 22.5 mg);

3. Member is responding positively to therapy;

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4. If request is for a dose increase, new dose is within FDA maximum limit for any FDA-approved indication or is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).


H. Other diagnoses/indications (must meet 1 or 2): 1. Currently receiving medication via a health plan affiliated with Envolve Pharmacy Solutions

and documentation supports positive response to therapy. Approval duration: Duration of request or 6 months (whichever is less); or

2. Refer to ERX.PA.01 if diagnosis is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized).

III. Diagnoses/Indications for which coverage is NOT authorized: A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient

documentation of efficacy and safety according to the off label use policies – ERX.PA.01 or evidence of coverage documents.

IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key CPP: central precocious puberty DSM-5: Diagnostic and Statistical Manual of Mental Disorders, 5th edition FDA: Food and Drug Administration GnRH: gonadotropin-releasing hormone LH: luteinizing hormone NCCN: National Comprehensive Cancer Network

Appendix B: Therapeutic Alternatives This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.

Drug Name Dosing Regimen Dose Limit/Maximum Dose

NSAIDs*: ibuprofen, naproxen, fenoprofen, ketoprofen, mefenamic acid, meclofenamate, indomethacin, tolmetin, diclofenac, etodolac, diflunisal, meloxicam, piroxicam

Endometriosis Varies – refer to specific prescribing information

Varies – refer to specific prescribing information

Combined oral estrogen-progesterone contraceptives: ethinyl estradiol + (desogestrel, ethynodiol diacetate, drospirenone, etonogestrel, levonorgestrel, norelgestromin, norethindrone, norgestimate, or norgestrel); estradiol valerate + dienogest; mestranol + norethindrone

Endometriosis 1 tablet PO QD (may vary per specific prescribing information)

1 tablet per day (may vary per specific prescribing information)

Progestin-only oral contraceptives: norethindrone

Endometriosis 0.35 mg PO QD

0.35 mg per day

Depot injection progestin contraceptives: medroxyprogesterone acetate

Endometriosis IM: 150 mg per 3 months (every 13 weeks) SC: 104 mg per 3 months (every 12 to 14 weeks)

See regimen

Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. *Examples provided may not be all-inclusive

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Appendix C: Contraindications/Boxed Warnings • Contraindication(s):

o Known hypersensitivity to GnRH, GnRH agonist analogs or any of the components of the individual products (all leuprolide products);

o Pregnancy (all leuprolide products except Eligard); o Lupron 3.75 mg/11.25 mg and Lupaneta Pack:

Undiagnosed abnormal vaginal bleeding Breast-feeding If used with norethindrone acetate

• Thrombophlebitis, thromboembolic disorders, cerebral apoplexy, or a past history of these conditions;

• Markedly impaired liver function or liver disease; • Known or suspected carcinoma of the breast.

• Boxed warning(s): none reported

V. Dosage and Administration Drug Name Indication Dosing Regimen Maximum

Dose Leuprolide acetate injection

Prostate cancer Leuprolide acetate injection (SC): 1 mg per day

See regimen

Leuprolide acetate (Lupron Depot 7.5,

Lupron Depot (IM) - 7.5 mg per month; 22.5 mg per 3 months; 30 mg per 4 months; 45 mg per 6 months

See regimen

22.5, 30, 45)

Leuprolide acetate (Eligard 7.5, 22.5, 30, 45)

Eligard (SC) - 7.5 mg per month; 22.5 mg per 3 months; 30 mg per 4 months; 45 mg per 6 months

See regimen

Leuprolide acetate (Lupron Depot 3.75, 11.25)

Leuprolide acetate (Lupaneta Pack 3.75, 11.25)

Endometriosis Lupron Depot/Lupaneta Pack (IM) - 3.75 mg per month; 11.25 mg per 3 months

See regimen

Leuprolide acetate (Lupron Depot 3.75)

Uterine fibroids Lupron Depot (IM) - 3.75 mg/month, 11.25 mg per 3 months

See regimen

Leuprolide acetate injection

Leuprolide acetate (Lupron Depot-Ped 7.5, 11.25, 15 [1 mo]; 11.25, 30 [3 mo])

CPP Leuprolide acetate (SC): • Diagnostic: 20 mcg/kg or as needed; • Treatment: Initial: 50 mcg/kg/day; titrate dose upward by 10 mcg/kg/day if down-regulation is not achieved (higher mg/kg doses may be required in younger children).

See regimen

Lupron Depot-Ped (IM): Monthly administration weight-based starting dose: 7.5 mg (≤ 25 kg), 11.25 mg (> 25 to 37.5 kg), 15 mg (> 37.5 kg) (increase as needed to 15 mg/month); 3-month administration: 11.25 mg or 30 mg

See regimen

Fensolvi (SC): 45 mg once every six months

See regimen


Breast cancer Lupron Depot (IM) 3.75 mg per month See regimen

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Drug Name Indication Dosing Regimen Maximum Dose


Ovarian cancer Lupron Depot (IM) 3.75 mg per month, 11.25 mg per 3 months

See regimen



Salivary Gland tumors

Lupron Depot (IM) - 7.5 mg per month; 22.5 mg per 3 months.

Eligard (SC) - 7.5 mg per month; 22.5 mg per 3 months; 30 mg per 4 months; 45 mg per 6 months

See regimen

VI. Product Availability Drug Name Leuprolide acetate injection (generic)

Availability Kit: 2.8 mL multi-dose vial (1 mg/0.2 mL)


Kit: 7.5 mg (1 month), 22.5 mg (3 month), 30 mg (4 month), 45 mg (6 month)

Leuprolide acetate (Lupron Depot 7.5, 22.5, 30, 45)

Prefilled syringe: 7.5 mg (1 month), 22.5 mg (3 month), 30 mg (4 month), 45 mg (6 month)

Leuprolide acetate and norethindrone acetate tablets (Lupaneta Pack 3.75, 11.25)

Pack: 3.75 mg leuprolide acetate syringe (1 month) with 5 mg norethindrone tablets Pack: 11.25 mg leuprolide acetate syringe (3 month) with 5 mg norethindrone tablets


Prefilled syringe: 3.75 mg (1 month)


Prefilled syringe: 11.25 mg (3 month)

Leuprolide acetate (Lupron Depot-Ped 7.5, 11.25)

Prefilled syringe: 7.5 mg (1 month), 11.25 mg (1 month), 15 mg (1 month) Prefilled syringe: 11.25 mg (3 month), 30 mg (3 month)

VII. References 1. Leuprolide Acetate Injection Prescribing Information. Bedford, OH: Ben Venue Laboratories, Inc.;

August 2007. Available at https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89658d24-2417-4053-a1a4-c38d32db7221. Accessed September 10, 2020.

2. Eligard Prescribing Information. Fort Collins CO: TOLMAR Pharmaceuticals, Inc.; April 2019. Available at http://eligardhcp.com/sites/default/files/pdfs/ELI_Full_PI.pdf. Accessed September 10, 2020.

3. Lupaneta Pack 3.75 Prescribing Information. North Chicago, IL: AbbVie Inc.; June 2015. http://rxabbvie.com/pdf/lupaneta_3_75_pi.pdf. Accessed September 10, 2020.

4. Lupaneta Pack 11.25 Prescribing Information. North Chicago, IL: AbbVie Inc.; June 2015. http://rxabbvie.com/pdf/lupaneta_11_25_pi.pdf. Accessed September 10, 2020.

5. Lupron Depot 3.75 Prescribing Information. North Chicago, IL: AbbVie Inc.; October 2013 Available at https://www.rxabbvie.com/pdf/lupron3_75mg.pdf. Accessed September 10, 2020.

6. Lupron Depot 11.25 mg Prescribing Information. North Chicago, IL: AbbVie Inc.; March 2020. Available at https://www.rxabbvie.com/pdf/lupron3month11_25mg.pdf . Accessed September 10, 2020.

7. Lupron Depot 7.5, 22.5, 30, 45 mg Prescribing Information. North Chicago, IL: AbbVie, Inc., March 2019. Available at http://www.rxabbvie.com/pdf/lupronuro_pi.pdf. Accessed September 10, 2020.

8. Lupron Depot-PED Prescribing Information. North Chicago, IL: AbbVie Inc.; April 2020. Available at: http://www.rxabbvie.com/pdf/lupronpediatric.pdf. Accessed September 10, 2020.

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https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89658d24-2417-4053-a1a4-c38d32db7221https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89658d24-2417-4053-a1a4-c38d32db7221http://eligardhcp.com/sites/default/files/pdfs/ELI_Full_PI.pdfhttp://rxabbvie.com/pdf/lupaneta_3_75_pi.pdfhttp://rxabbvie.com/pdf/lupaneta_11_25_pi.pdfhttps://www.rxabbvie.com/pdf/lupron3_75mg.pdfhttps://www.rxabbvie.com/pdf/lupron3month11_25mg.pdfhttp://www.rxabbvie.com/pdf/lupronuro_pi.pdfhttp://www.rxabbvie.com/pdf/lupronpediatric.pdf


9. National Comprehensive Cancer Network Drugs and Biologics Compendium. Leuprolide acetate. Available at nccn.org. Accessed September 10, 2020.

10. National Comprehensive Cancer Network Drugs and Biologics Compendium. Leuprolide acetate for depot suspension. Available at nccn.org. Accessed September 10, 2020.

11. National Comprehensive Cancer Network. Prostate cancer (Version 2.2020). Available at https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf. Accessed September 10, 2020.

12. National Comprehensive Cancer Network. Breast cancer (Version 6.2020). Available at https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Accessed September 10, 2020.

13. National Comprehensive Cancer Network. Ovarian cancer (Version 1.2020). Available at https://www.nccn.org/professionals/physician_gls/pdf/ovarian.pdf. Accessed September 10, 2020.

14. Committee on Practice Bulletins - Gynecology. Management of endometriosis. July 2010 (reaffirmed 2016); 116(1): 223-236.

15. Donnez J, Dolmans MM. Uterine fibroids management: From the present to the future. Hum Reprod Update. November 2016; 22(6): 665-686.

16. MS DeLaCruz, EM Buchanan. Uterine fibroids: Diagnosis and treatment. Am Fam Physician. January 15, 2017; 95(2): 100-107.

17. Marret H, Fritel X, Ouldamer L et al. Therapeutic management of uterine fibroid tumors: Updated French guidelines. Eur J Obstet Gynecol Reprod Biol. December 2012; 165(2): 156–164.

18. Kaplowitz P, Bloch C. Evaluation and referral of children with signs of early puberty. Pediatrics. 2016; 137(1): e20153732.

19. Falcone T, Flyckt R. Clinical Management of Endometriosis. Obstetrics & Gynecology. 2018;131(3):p557-571

Gender Dysphoria 20. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 5th ed.

Arlington, VA: American Psychiatric Association Publishing; 2013. 21. Hembree WC, Cohen-Kettenis PT, Gooren L, et al. Endocrine treatment of gender-dysphoric/gender-

incongruent persons: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab, November 2017, 102(11):3869–3903.

22. Rafferty J. Ensuring comprehensive care and support for transgender and gender-diverse children and adolescents. Policy statement. American Academy of Pediatrics. Pediatrics; 142(4), October 2018:e20182162.

23. Deutsch MB. Guidelines for the primary and gender-affirming care of transgender and gender nonbinary people. Center of Excellence for Transgender Health. Department of Family & Community Medicine, University of California, San Francisco; 2nd Ed, published June 17, 2016.

24. Standards of care for the health of transsexual, transgender, and gender nonconforming people. WPATH: World Professional Association for Transgender Health. 7th version; 2001. Available at www.wpath.org.

25. Wylie KR, Fung R, Boshier C, Rotchell M. Recommendations of endocrine treatment for patients with gender dysphoria. Sexual and Relationship Therapy Vol. 24, No. 2, May 2009, 175–187.

26. Emmanual M, Bokor BR. Tanner Stages. Treasure Island, FL: StatPearls Publishing; 2019 Jan. Available at https://www.ncbi.nlm.nih.gov/books/NBK470280/. Last update: May 13, 2019. Accessed Accessed September 10, 2020.

27. Micromedex® Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed September 10, 2020.

Reviews, Revisions, and Approvals Date P&T Approval

Date Converted to new template. All indications: Specified which formulations can be requested for each indication. Added pregnancy CI. Added preferencing criteria per formulary. For re-auth, added requirement for positive response to therapy. CPP: Added lower age limit of 2 years per PI (should not be used in those < 2 years). Endometriosis/pelvic pain: Modified trial requirement to require both NSAIDs

07.17 08.17

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https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdfhttps://www.nccn.org/professionals/physician_gls/pdf/breast.pdfhttps://www.nccn.org/professionals/physician_gls/pdf/ovarian.pdfhttp://www.wpath.org/https://www.ncbi.nlm.nih.gov/books/NBK470280/http:nccn.orghttp:nccn.org


Reviews, Revisions, and Approvals Date P&T Approval

Date and oral contraceptives. Prostate cancer: NCCN recommended uses added. Doses removed. Off-label uses are referred to the off-label use policy. 4Q17 Annual Review Dosing added to oncology criteria. Positive therapeutic response examples added to oncology and endometriosis criteria. Oncology FDA/NCCN (categories 1 and 2A) indications listed separately. Pelvic pain criteria deleted with direction to suspected endometriosis if appropriate. Endometriosis step therapy edited from estrogen/progestin OC to OC or depot contraceptive or progestin. Total approval duration increased from 6 to 12 months. Concomitant iron therapy and specific time period within which surgery must be performed are removed from fibroid criteria. Total approval duration increased from 3 to 6 months. Specialist requirement added for endometriosis, fibroids, CPP. Preferencing removed for CPP.

09.17 11.17

4Q 2018 annual review: no significant changes; for oncology, summarized NCCN and FDA-approved uses for improved clarity (limited to diagnosis) and added specialist involvement in care; references reviewed and updated.

08.07.18 11.18

Addition of gender dysphoria as off-label use. 07.16.19 08.194Q 2019 annual review: Prostate cancer – removed Eligard redirection as it is on the formulary with similar placement to alternatives, added urologist specialist option; references reviewed and updated.

08.01.19 11.19

Added Fensolvi (new dosage form) to the policy for Central Precocious Puberty; added off-label NCCN indication and criteria for salivary gland tumor; references reviewed and updated.

05.07.20 08.20

4Q 2020 annual review: no significant changes; references reviewed and updated.

09.10.20 11.20

Important Reminder This clinical policy has been developed by appropriately experienced and licensed health care professionals based on a review and consideration of currently available generally accepted standards of medical practice; peer-reviewed medical literature; government agency/program approval status; evidence-based guidelines and positions of leading national health professional organizations; views of physicians practicing in relevant clinical areas affected by this clinical policy; and other available clinical information.

This Clinical Policy is not intended to dictate to providers how to practice medicine, nor does it constitute a contract or guarantee regarding payment or results. Providers are expected to exercise professional medical judgment in providing the most appropriate care, and are solely responsible for the medical advice and treatment of members.

This policy is the property of Envolve Pharmacy Solutions. Unauthorized copying, use, and distribution of this Policy or any information contained herein is strictly prohibited. By accessing this policy, you agree to be bound by the foregoing terms and conditions, in addition to the Site Use Agreement for Health Plans associated with Envolve Pharmacy Solutions.

©2016 Envolve Pharmacy Solutions. All rights reserved. All materials are exclusively owned by Envolve Pharmacy Solutions and are protected by United States copyright law and international copyright law. No part of this publication may be reproduced, copied, modified, distributed, displayed, stored in a

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retrieval system, transmitted in any form or by any means, or otherwise published without the prior written permission of Envolve Pharmacy Solutions. You may not alter or remove any trademark, copyright or other notice contained herein.

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See Important Reminder at the end of this policy for important regulatory and legal information.DescriptionFDA Approved Indication(s):Policy/Criteria

I. Initial Approval CriteriaApproval duration: 12 monthsApproval duration: 6 monthsApproval duration: 3 monthsApproval duration: 12 monthsApproval duration: 12 monthsApproval duration: 12 monthsII. Continued TherapyApproval duration: 12 monthsApproval duration: 6 monthsApproval duration: 3 monthsApproval duration: 12 monthsApproval duration: 12 monthsApproval duration: 12 monthsApproval duration: Duration of request or 6 months (whichever is less); orV. Dosage and AdministrationImportant Reminder

erx.spa.147 leuprolide acetate (eligard, fensolvi, lupaneta … · 2020. 12. 23. · leuprolide...

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